Selective serotonin reuptake inhibitors and malformations: case closed?
Gideon Koren1, Hedvig M E Nordeng
1The Motherisk Program, Division of Clinical Pharmacology/Toxicology, Hospital for Sick Children, Toronto, Ontario M5G 1X8, Canada. gkoren@sickkids.ca
Selective serotonin reuptake inhibitors (SSRIs) do not increase the risk of cardiac malformations in infants. Ascertainment bias in depressed pregnant women, whether treated or not, likely explains previous findings.
Area of Science:
- Perinatal mental health
- Pharmacovigilance
- Reproductive medicine
Background:
- Selective serotonin reuptuptake inhibitors (SSRIs) are frequently prescribed to pregnant women for depression.
- Previous studies suggested a potential link between SSRI use during pregnancy and increased risk of infant cardiac malformations.
- This has raised concerns among patients and clinicians, potentially leading to treatment cessation.
Purpose of the Study:
- To evaluate the association between SSRI use in pregnancy and the risk of congenital cardiac malformations.
- To address the concerns and anxiety surrounding SSRI use during pregnancy.
Main Methods:
- Analysis of administrative databases.
- Comparison of cardiac malformation rates in infants exposed to SSRIs versus unexposed infants.
- Consideration of maternal depression as a confounding factor.
Main Results:
- Recent evidence indicates a similar increased risk of cardiac malformations in infants of depressed mothers not using SSRIs.
- Ascertainment bias, due to increased diagnostic testing in depressed women (treated or untreated), is proposed as the likely explanation.
- Data suggest SSRIs do not elevate the risk of cardiovascular malformations.
Conclusions:
- The observed association between SSRI use and cardiac malformations is likely due to ascertainment bias, not a direct effect of SSRIs.
- Pregnant women with depression can be reassured regarding the cardiovascular safety of SSRIs.
- Continued use of necessary SSRI therapy during pregnancy is supported by current evidence.
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